New shingles vaccine poses quandary for older-60 crowd

Should adults over 60 who want protectionwait a few years until shot is approved?

Public-health experts were pleased last month when a study showed that GlaxoSmithKline's experimental shingles vaccine is much more effective than the established Merck vaccine.

In the long run, the prospect of a better shingles shot could improve vaccination rates among people 60 and older, now only 24 percent.

But in the short run, the news creates a bit of a quandary: Should older adults who want protection wait, probably a few years, for approval of the new vaccine, and hope the herpes zoster virus doesn't rear its excruciating rash in the meantime?

"That's a hard question," said Stephanie Bialek, a herpes virus expert at the U.S. Centers for Disease Control and Prevention. "It's one we expect a lot of people to have.

And one that cannot yet be answered because the new vaccine is still being studied, she said.

Shingles is related to chicken pox. After the itchy, unsightly blisters of chicken pox disappear, the varicella-zoster virus goes dormant in nerve cells.

Years or decades later, the virus erupts as shingles in a quarter of infected adults, more than a million a year. People who live to 85 have a 50-50 chance of developing the disease.

Shingles can recur. The virus can even affect the eyes, a sight-threatening emergency called herpes zoster ophthalmicus. And about 10 percent of shingles sufferers are left with a complication called postherpetic neuralgia, a debilitating nerve pain that can persist indefinitely.

Exactly why the virus reactivates is unclear, but age-related declines in immune protection play a role because shingles usually occurs after age 50.

The Merck vaccine, Zostavax, was approved in 2006 for people age 50 and over, and is recommended for ages 60 and over. (Most insurers cover it at age 60.)

Zostavax, made with a weakened form of the herpes zoster virus, is less effective in older people- those more likely to get the disease. It reduces shingles by 70 percent among those in their 50s, by 64 percent among people in their 60s, and by 38 percent among people 70 and older. It also reduces postherpetic neuralgia by about 67 percent in all groups and may lessen the severity of a shingles recurrence.

The Glaxo vaccine, in contrast, is made from a single viral protein combined with a novel immune-stimulating substance known as an adjuvant.

"It's a completely different approach," said Thomas Heineman, head of Glaxo's global vaccine development division. "The new adjuvant was developed by (Glaxo) and has been used in trials of vaccines for malaria, hepatitis B, and tuberculosis."

The international study of the shingles immunization, published last month in the New England Journal of Medicine, gave two doses of either the Glaxo vaccine or a placebo to 15,400 people age 50 and over.

Only six vaccine recipients in the entire group developed shingles over the three-year follow-up, compared to 210 in the placebo group, making the vaccine about 97 percent effective. Moreover, age did not diminish the potency; among people 70 and older, the vaccine was 98 percent effective.

With any adjuvant, there is a hypothetical risk of overstimulating the immune system, but Heineman said "that is not something we've seen." Though the vaccine group reported more temporary injection-site reactions and body-wide complaints than those who got the placebo, the numbers of serious side effects, autoimmune disease, and deaths were similar in both groups.

Glaxo has not said when it hopes to file government approval of the vaccine. The company is completing studies of the vaccine in people age 70 and older and in immune-compromised patients, for whom the current vaccine is not safe. A U.S. Food and Drug Administration review can take six months or more.

One question Glaxo "has no formal plans at this point" to explore, Heineman said, is whether people who have had Zostavax could also get the Glaxo vaccine.